# K243291: Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)

- Pathway: 510(k) (Traditional)
- Applicant: Neoventa Medical AB
- Decided: Jan 17, 2025 after 91 days
- Product code: HGP (Electrode, Circular (Spiral), Scalp And Applicator)
- Device class: 2
- Regulation: 21 CFR 884.2675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K771553 (1977). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030691: Fetal Spiral Electrode, Model FSE07000, Clinical Innovations, Inc. (2003) Summary page 5.

## Indications for use
Goldtrace FSE is indicated for patients requiring continuous electronic intrapartum monitoring of the fetal heart rate during labor and delivery.

Source page: https://510kreport.com/device/K243291
Methodology: https://510kreport.com/methodology